Department of Health and Human Services September 27, 2011 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 17, 2011, Pages 35452-3 and allowed 60 days for public comment. Three (3) comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Healthy Communities Study: How Communities Shape Children's Health (HCS). Type of Information Collection Request: New. Need and Use of Information Collection: The HCS will address the need for a cross-cutting national study of community programs and policies and their relationship to childhood obesity. The HCS is an observational study of communities conducted over five years that aims to (1) Determine the associations between community programs/policies and Body Mass Index (BMI), diet, and physical activity in children; and (2) identify the community, family, and child factors that modify or mediate the associations between community programs/policies and BMI, diet, and physical activity in children. A total of 279 communities and over 23,000 children and their parents will be part of the HCS over the five-year study. A HCS community is defined as a high school catchment area and the age range of children is 3-15 years upon entry into the study. The study examines quantitative and qualitative information obtained from community-based initiatives; community characteristics (e.g., school environment); measurements of children's physical activity levels and dietary practices; and children's and parents' BMIs. Results from the Healthy Communities Study may influence the future development and funding of policies and programs to reduce childhood obesity. Furthermore, HCS results will be published in scientific journals and will be used for the development of future research initiatives targeting childhood obesity. Frequency of Response: Varies by participant type from once to 2.74 times. Affected Public: Families or households; businesses, other for-profit, and non-profit. Type of Respondents: Parents, children, community key informants (who have knowledge about community programs/ policies related to healthy nutrition, physical activity, and healthy weight of children), food service personnel, physical education instructors, state health department employees, and physicians or medical secretaries. The annual reporting burden is as follows: Estimated number of respondents: 247,619; Estimated Number of Responses per Respondent: 1.1; Average (Annual) Burden Hours per Response: 0.12; and Estimated Total Burden Hours Requested: 33,144. The annualized cost to respondents is estimated at $434,789. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is confirming the effective date of June 6, 2011, for the final rule that appeared in the Federal Register of May 4, 2011 (76 FR 25234). The final rule amended the color additive regulations to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl] amino]- 9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (CAS Reg. No. 70209-99- 3), also known as Reactive Blue 69, as a color additive in contact lenses.

This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the following 7 grantees: Columbia University Mailman School of Public Health, New York, NY; Johns Hopkins University, Baltimore, MD, Texas A&M School of Rural Public Health, College Station, TX; University at Albany SUNY School of Public Health, Albany, NY; University of Oklahoma College of Public Health, Oklahoma City, OK; University of South Florida College of Public Health, Tampa, FL. The purpose of the PERLC program is to develop, deliver, and evaluate core competency-based training and education that target the public health workforce, address the public health preparedness and response needs of state, local, and tribal public health authorities and emphasize essential public health security strategies. These activities are proposed by the above mentioned grantees in their FY 2011 application submitted under Funding Opportunity Announcement CDC-RFA-TP10-1001, ``Preparedness and Emergency Response Learning Centers (PERLC),'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.069. Approximately $5,000,000 in ACA funding will be awarded to the grantee for sustaining approved program activities. Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Section 4002 (42 U.S.C. 300u-11) (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published Funding Opportunity Announcement of CDC-RFA-TP10-1001:

This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the following 4 Preparedness and Emergency Response Research Center (PERRCs) grantees: the University of North Carolina in Chapel Hill, NC; the University of Minnesota in Minneapolis, MN; the University of California in Berkeley; and the University of California in Los Angeles, CA. The purpose of the PERRC program is to conduct public health systems research to strengthen preparedness and response capabilities at the national, state, local, and tribal levels for preventing morbidity and mortality from threats to the public's health such as infectious disease outbreaks, and man-made and natural disasters. These activities are proposed by the above mentioned grantees in their FY 2011 application for continuation submitted under Funding Opportunity Announcement RFA-TP-08-001, ``Preparedness and Emergency Response Research Centers: A Public Health Systems Approach,'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.061 Approximately $5,000,000 in ACA funding will be awarded to these grantees for sustaining approved program activities. Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Section 4002 (42 U.S.C. 300u-11) (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published Funding Opportunity Announcement of RFA-TP-08-001: